L19IL2/TNF in Patients With Basal Cell Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
Philogen S.p.A.
Study ID
NCT07227870
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Basal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • L19IL2/L19TNF — DRUG
    intratumoral administrations

Study Details

Open-label, single-arm, multicentre study in patients with locally advanced BCC amenable to intratumoral injection, who have progressed on or are intolerant to systemic therapy as determined by a local multidisciplinary tumor board. The primary objective of the study is to evaluate the activity of intratumoral L19IL2/L19TNF, while the secondary objective is to assess the safety and efficacy. The patients will receive multiple intratumoral administrations of combined L19IL2 and L19TNF to all injectable cutaneous and subcutaneous lesions once weekly for up to 4 weeks: for those who have a partial response or stable disease as their best response, a second 4-week course L19IL2/L19TNF of four weekly injections may be administered as per treating physician judgement. Patients will be followed for a maximum of 160 weeks after beginning of treatment.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2031
Completion
Feb 28, 2031

Study Design

Enrollment
92 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Patients will receive intratumoral administrations of L19IL2/L19TNF into injectable cutaneous, subcutaneous tumors and nodal or in transit metastasis once weekly for up to 4 weeks.

Primary Outcome Measure

Best Overall Response Rate (BORR) [ Time Frame: From enrollment up to a maximum of 160 weeks after the start of treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.TampaFlorida33612
Jonathan S Zager, MD (PRINCIPAL_INVESTIGATOR)
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322
Michael C. Lowe, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Michael R Migden, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.· Tampa, FLWinship Cancer Institute, Emory University· Atlanta, GAThe University of Texas MD Anderson Cancer Center· Houston, TX

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